Home » Topics » Regulatory » EMA

EMA
RSS

Bio-Path Holdings' BP-1001 awarded orphan drug status from EMA

Nov. 4, 2016

FDA and EMA accept Novartis' applications for ribociclib plus letrozole in advanced breast cancer

Nov. 2, 2016

EMA accepts PharmaMar's MAA for plitidepsin

Oct. 31, 2016

Biogen gives update on regulatory applications for nusinersen in E.U., U.S.

Oct. 31, 2016

EMA accepts for review MAA for niraparib in ovarian cancer

Oct. 28, 2016

EMA issues positive opinion recommending orphan drug designation for La Jolla's LJPC-401

Oct. 25, 2016

EMA awards priority medicine designation to CymaBay Therapeutics' MBX-8025

Oct. 21, 2016

EMA gives orphan drug designation to gene therapy program ABO-102

Oct. 19, 2016

EMA grants orphan designation to Iomab-B

Oct. 19, 2016

EMA grants PRIME access to Atara's EBV-CTL

Oct. 19, 2016

Popular Stories

Today's news in brief
BioWorld
BioWorld briefs for May 6, 2026.
News in brief
BioWorld Asia
BioWorld Asia briefs for May 5, 2026
Cytospire raises £61M series A to target EGFR in solid tumors
BioWorld
Next-generation T-cell engager (TCE) specialist Cytospire Therapeutics Ltd. has raised £61 million (US$82.7 million) in a series A round, equipping it to advance...
Bio Korea 2026: US policy risks shift to execution framework
BioWorld
Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies...
Regulatory actions for May 5, 2026
BioWorld
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Adma, Applied...